Celgene Principal Scientist, Drug Substance Development in Summit, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Principal Scientist, Drug Substance Development
Serve as a key member of a dynamic, scientifically driven team dedicated to the discovery and development of elegant chemical syntheses and processes for active pharmaceutical compounds. Represent Drug Substance Development (DSD) on multidisciplinary Chemistry Manufacturing, and Controls (CMC) teams with direct scientific responsibility and oversight of DSD staff. Apply fundamental chemistry and engineering principles to solve challenges in synthesis and process development from bench through pilot plant manufacture. Develop and execute phase appropriate risk-based development and drug substance supply plans. Manufacture development candidates for pre-IND studies. Manage technology transfers to and support manufacturing of GMP Drug Substance (DS) at Contract Research Organizations. Conduct DS related due diligence assessments for potential external collaborations. Serve as Celgene DSD representative on external collaborations. Remaining current with required GMP training and qualifications. Apply cGMP principles by following internal standard operating procedures (SOPs), work practices (WPs), and regulatory requirements. Assist in the preparation of CMC regulatory documents. Evaluate and maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals. Serve as a resource of scientific and technical expertise. Supervise scientists under a project specific matrix organization. Prepare technical reports, publications and oral presentations. Enhance the scientific and business capabilities of the department.
Ph.D. in Organic Chemistry with 8 + years relevant industrial experience.
Excellent laboratory skills and knowledge of organic synthesis. Proficient in the use and interpretation of NMR, HPLC, MS, IR, DSC, TGA, XRD, and automation.
Experience in pharmaceutical development as it relates to route selection, process development, salt selection, polymorphism, solubility, and stability testing.
Proven track record in developing and scaling-up innovative, safe, and effective processes for the manufacture of chemical intermediates and drug substances. Demonstrated record of implementing creative solutions to overcome synthetic and manufacturing obstacles.
Extensive patent and academic journal publication record a plus.
Ability to balance scientific, legal, and business needs as they relate to a given project.
Ability to balance multiple projects at different levels, must be able to concomitantly work effectively in the lab and as a project manager.
Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary team environment. Ability to work independently or in team environments under deadlines.
Excellent verbal skills are essential, must be able to contextualize complex issues for colleagues in and outside of the department.
Solid writing skills are critical, must be able to succinctly capture technical and project related information from diverse sources.
Experience with CMC issues encountered in drug development.
Familiarity with GMP manufacturing and regulatory filings.
Direct or indirect supervisory experience.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.